Systems and methods for sealing a vascular puncture

ABSTRACT

Systems and methods introduce a closure material to seal a vessel puncture site. The system and methods provide a catheter adapted for passage through a tissue puncture and sized to occupy substantially all the tissue puncture. The catheter includes a lumen in fluid communication with a fluid delivery port adjacent the catheter distal end. One or more dispensers are in fluid communication with the catheter lumen for dispensing first and second fluid compositions in the catheter lumen. An actuator causes the first and second fluid compositions to be dispensed from the dispensers and mixed by flowing the first and second fluid compositions through a static mixer. The first and second fluid compositions are dispensed from the fluid delivery port as a fluid mixture that reacts in situ to form a nonfluent closure composition adjacent the vessel puncture site.

RELATED APPLICATIONS

This application is a continuation of co-pending U.S. Application. Ser.No. 10/406,017, filed Apr. 3, 2003, which is a divisional of U.S.application Ser. No. 10/132,848, filed Apr. 23, 2002, now U.S. Pat. No.6,562,059, which is a divisional of U.S. application Ser. No.09/334,300, filed Jun. 16, 1999, now abandoned, which is a continuationof U.S. application Ser. No. 08/963,408, filed Nov. 3, 1997, now U.S.Pat. No. 6,033,401, which claims the benefit of Provisional U.S.Application Ser. No. 60/036,299, filed Mar. 12, 1997, entitled“Universal Introducer.”

FIELD OF THE INVENTION

This invention relates to a vessel closure device, and more particularlyto a device for effecting the closure of a vessel by delivering a fluentclosure composition precursor and converting the composition in situ toa non-fluent closure composition.

BACKGROUND OF THE INVENTION

A wide variety of surgical procedures are performed by the introductionof a catheter into a vessel. After the surgical procedure is completed,closure of the vessel at the site where the catheter was introduced isneeded. Vessel punctures formed in the process of performing a catheterbased surgical procedure are commonly 1.5 mm to 7.0 mm in diameter andcan be larger. Closure of these punctures is frequently complicated byanticoagulation medicine given to the patient which interferes with thebody's natural clotting abilities.

Closure of a vessel puncture has traditionally been performed byapplying pressure to the vessel adjacent the puncture site. Thisprocedure requires the continuous attention of at least one medicalstaff member to apply pressure to the vessel puncture site and can takeas long as 30 minutes.

Devices have been developed for effecting the closure of vesselpunctures through the application of energy. See U.S. Pat. Nos.5,626,601; 5,507,744; 5,415,657; and 5,002,051. Devices have also beendeveloped for effecting the closure of vessel punctures through thedelivery of a mechanical mechanism which mechanically seals thepuncture. See U.S. Pat. Nos. 5,441,520; 5,441,517; 5,306,254; 5,282,827;and 5,222,974. Devices have also been developed for effecting theclosure of vessel punctures through the delivery of a composition toblock the vessel puncture. See U.S. Pat. Nos. 5,601,602; 5,591,205;5,441,517; 5,292,332; 5,275,616; 5,192,300; and 5,156,613. Despite thevarious devices that have been developed for closing vessel punctures, aneed still exists for a simple, safe and inexpensive device and methodfor closing vessel punctures.

SUMMARY OF THE INVENTION

One aspect of the invention provides an assembly for introducing aclosure material to seal a vessel puncture site. The closure materialcomprises a mixture of a first and second fluid composition which, uponmixing, react to form a nonfluent closure composition. The assemblycomprises a catheter sized and configured for passage through a tissuepuncture. The catheter has at least one fluid delivery port adjacent thecatheter distal end and adapted to occupy a position adjacent the vesselpuncture site. The catheter includes a lumen that is in fluidcommunication with the fluid delivery port. One or more dispensers areprovided in fluid communication with the catheter lumen for dispensingthe first and second fluid compositions in the catheter lumen. Anactuator is provided for causing the first and second fluid compositionsto be dispensed from the one or more dispensers and mixed by flowing thefirst and second fluid compositions through a static mixer. The firstand second fluid compositions are dispensed from the fluid delivery portas a fluid mixture that reacts in situ to form the nonfluent closurecomposition adjacent the vessel puncture site. The catheter is sized toblock flow of the fluid mixture from the fluid delivery port into asubstantial part of the tissue puncture.

In one embodiment, the static mixer is a cartridge. In anotherembodiment, the static mixer is incorporated into the catheter.

Another aspect of the invention provides a method for sealing a vascularpuncture site. A catheter is introduced through a tissue puncture. Thecatheter is sized to occupy substantially all the tissue puncture andincludes at least one fluid delivery port adjacent the distal end of thecatheter adapted to be positioned adjacent the vessel puncture site.First and second fluid compositions are provided which; upon mixing,react to form a nonfluent closure composition. The first and secondfluid compositions are mixed by flowing the components through a staticmixer that communicates with the fluid delivery port. The first andsecond fluid compositions are dispensed from the fluid delivery port asa fluid mixture that reacts in situ to form the nonfluent closurecomposition adjacent the vessel puncture site. The size of the catheterblocks flow of the fluid mixture from the fluid delivery port into asubstantial part of the tissue puncture, whereby a localized in situclosure forms adjacent the vessel puncture site to seal the vesselpuncture site.

In one embodiment, the static mixer is a cartridge. In anotherembodiment, the static mixer is incorporated into the catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of a closure device according to the presentinvention.

FIG. 1B is a cross section of the closure device of FIG. 1A.

FIG. 2 is a cross section of a closure device with a first and secondclosure lumen coupled to first and second closure composition precursorsources.

FIG. 3A is a side view of a closure device including a guidewire lumenconfigured to accommodate a guidewire.

FIG. 3B is a cross section of a closure device illustrated in FIG. 3A.

FIG. 4A illustrates a sheath with a distal end disposed within a vessel.

FIG. 4B illustrates a closure device disposed within the sheath suchthat the distal end of the closure device extends beyond the distal endof the sheath.

FIG. 4C illustrates the sheath and closure device withdrawn from thevessel until the position sensing mechanism is located outside thevessel adjacent the puncture.

FIG. 4D illustrates a closure composition precursor source coupled tothe closure device of FIG. 4C. The closure composition precursor isdelivered through the closure lumen to the puncture.

FIG. 4E illustrates the puncture after the closure device of FIG. 4D iswithdrawn from the puncture.

FIG. 4F illustrates the puncture after the closure device is completelywithdrawn from the tissue site.

FIG. 5A is a side view of a locking mechanism coupled to a closuredevice and threads on a sheath.

FIG. 5B is a side view of the locking mechanism of FIG. 5A coupled tothe threads on a sheath.

FIG. 6A illustrates a sheath with a distal end disposed within a vessel.

FIG. 6B illustrates a guidewire disposed within the sheath of FIG. 6A.

FIG. 6C illustrates the sheath of FIG. 6B withdrawn along the guidewire.

FIG. 6D illustrates a closure device threaded along the guidewire ofFIG. 6C until the distal end of the device is disposed within a vessel.

FIG. 6E illustrates the closure device of FIG. 6D after the guidewirehas been withdrawn. The closure device is withdrawn until the positionsensing mechanism is located outside the vessel adjacent the puncture.

FIG. 6F illustrates a closure composition precursor source coupled tothe closure device of FIG. 6E. The closure composition precursor isdelivered through the closure lumen to the puncture.

FIG. 6G illustrates the puncture after the closure device is completelywithdrawn from the tissue site.

FIG. 7A is a side view of a closure device including a fiber optic ringas a energy delivery device.

FIG. 7B is a cross section of the fiber optic ring of FIG. 7A.

FIG. 8A is a side view of a closure device with a contact switch as aposition sensing mechanism.

FIG. 8B is a side view of a contact switch of FIG. 8A being compressedby the vessel wall.

FIG. 9A is a cross section of a closure device containing a plurality ofprecursor exit ports coupled to a single closure lumen.

FIG. 9B is a cross section of a closure device containing a plurality ofprecursor exit ports coupled to a plurality of closure lumens.

FIG. 9C illustrates a closure device with a plurality of pressure portsand first and second closure lumens.

FIG. 10A is a side view of a closure device including a balloon as theposition sensing device.

FIG. 10B illustrates the closure device of FIG. 10A disposed within avessel.

FIG. 11 illustrates a position sensing mechanism in the form of a curvedwire positioned within the vessel lumen.

FIG. 12A is a cross section of a closure device with a plurality ofclosure lumens and a static mixer.

FIG. 12B is a cross section of a static mixer which is a removablecartridge.

FIG. 13 is a cross section of a closure device which alternate theprecursor exit ports from a first closure compound with the precursorexit ports of a second closure compound.

FIG. 14A is a cross section of an anti-backflow valve.

FIG. 14B is a cross section of an anti-backflow valve.

FIG. 15A illustrates a flapper valve disposed within the distal end of aclosure device.

FIG. 15B is a side view of a flapper valve.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIGS. 1A and 1B illustrate a closure device 10 according to the presentinvention. The closure device 10 may be used to seal a puncture in avessel such as a femoral artery.

The closure device 10 includes an elongated body 12 with a proximal end14 and a distal end 16 sized to be inserted into a lumen of a vessel.The surface of the elongated body 12 is preferably made of a non-stickmaterial, such as Teflon, or coated with a biocompatible lubricant.Positioned within the elongated body 12 are one or more closure lumenswhich extend from adjacent the proximal end 14 of the device to thedistal end 16 of the device for introducing a closure compositionprecursor adjacent the vessel puncture site. Illustrated in FIGS. 1A and1B is a closure device 10 with a single closure lumen 18 with aprecursor entrance port 20 and at least one precursor exit port 22adjacent the distal end 16. The precursor entrance port 20 is preferablyremovably coupleable to a closure composition precursor source 24 forsupplying the closure composition precursor to the closure device 10.The closure lumen 18 may optionally contain an anti-backflow valve 26 toprevent blood from flowing into the closure lumen 18 from the vessel.

The closure composition precursor can be formed of one or more fluentmaterials that can be flowed from the closure composition precursorsource 24 to adjacent the device distal end 16 through the closure lumen18. The fluent closure composition precursor is transformed into anon-fluent closure composition in situ to effect closure of thepuncture. In a preferred embodiment, energy is applied to the closurecomposition precursor to accelerate its transformation into thenon-fluent closure composition. The transformation of the fluentprecursor to a non-fluent closure composition may be the result of aphase change (i.e. solidification) of the precursor or a chemicalmodification of the precursor. For example, the precursor may be formedfrom multiple components which react with each other, optionallyaccelerated by a catalyst or energy. Alternatively, the precursor may beformed from a single component which reacts with itself, also optionallyaccelerated by a catalyst or energy.

In embodiments where energy is applied, the body 12 includes an energydelivery device 28 adjacent the distal end 16. The energy deliverydevice 28 may be designed to deliver one or more different types ofenergy including but not limited to electromagnetic radiation (RF,microwave, ultraviolet, visible light, laser), ultrasound, resistiveheating, exothermic chemical heating, and frictional heating. The energysource may also function to withdraw energy, i.e., perform cooling. Theclosure device 10 may also include an energy source attachment mechanism30 for placing the energy delivery device 28 in energetic communicationwith an energy source 32.

The body 12 further includes at least one position sensing mechanism 34adjacent the distal end 16 of the closure device 10 for indicatingwhether the position sensing mechanism 34 is located within or outsideof the vessel 36. The position sensing mechanism 34 should be positionedon the body 12 distal to the precursor exit port 22 so that when theposition sensing mechanism 34 is outside the vessel 36 the precursorexit port 22 is also outside the vessel 36. FIG. 1A illustrates theclosure device 10 with a single position sensing mechanism 34. Asillustrated, the closure device 10 may also include a position monitorattachment port 38 for coupling the position sensing mechanism 34 to aposition monitor 40. Examples of a position sensing mechanisms include,but are not limited to, a pressure port and an electrical contactswitch.

Other sensors (not shown) may also be positioned on the body 12. Forinstance, a temperature sensor for measuring temperature adjacent thedistal end 16 of the body 12 and/or an impedance sensor may bepositioned at the distal end 16 of the closure device 10.

The body 12 can include two or more closure lumens for the introductionof closure composition precursor. For example, as illustrated in FIG. 2,a second closure lumen 42 may be coupled to a second closure compositionprecursor source 44 by a second precursor entrance port 46. The secondclosure lumen 42 may also contain an anti-backflow valve 26 to preventblood flow through the second closure lumen 42.

The closure composition precursor may be introduced adjacent the vesselpuncture as a single composition through a single closure lumen.Alternately, a first composition may be introduced through the closurelumen 18 and a second composition can be introduced through the secondclosure lumen 42, as illustrated in FIG. 2. The first and secondcompositions can be the same or different and can be introducedsimultaneously or at different times. The first and second compositionsmay interact to accelerate the transformation to the non-fluent closurecomposition at the tissue site 54, for example, by reacting with eachother or by one catalyzing the solidification of the other.

FIGS. 3A-3B illustrate another embodiment of the invention configured tobe used with a guidewire. As illustrated in FIG. 3A, the body 12 caninclude a guidewire lumen 48 configured to accommodate a guidewire. Theguidewire lumen 48 can include an anti-backflow valve or hemostasisvalve 50. FIG. 3B illustrates a cross-section of the device illustratedin FIG. 3B.

FIGS. 4A-4F illustrate a method of using the closure device 10illustrated in FIGS. 1A-1B. The closure device 10 is used after asurgical procedure where a vessel 36 such as a femoral artery has beenpunctured. Angioplasty is a typical surgery which results in puncturingthe femoral artery with a catheter. After the catheter devices from sucha surgical procedure have been removed, a sheath 52 typically remainswithin a tissue site 54 as illustrated in FIG. 4A. The sheath 52penetrates the skin 56 of the patient and passes through the underlyingtissue to a vessel 60. The distal end 16 of the sheath 52 is positionedthrough a puncture 62 in the vessel 60.

As illustrated in FIG. 4B, the closure device 10 is inserted into thesheath lumen 64. The position of the closure device 10 within the sheath52 may be set by fixing the closure device 10 to the sheath. Forexample, as illustrated, the closure device 10 may include a stop collar66 which may engage an upper flange 68 on the sheath 64. The distal end16 of the closure device 10 extends from the sheath 52 such that theposition sensor 30 and precursor exit port 22 are distal relative to thesheath 52 and positioned within the vessel 60.

As illustrated in FIG. 4C, the sheath 52 and closure device 10 aresimultaneously withdrawn until the position sensor 30 is sensed to belocated outside the vessel 60. Since the precursor exit port 22 ispositioned distal relative to the position sensor 30, the precursor exitport 22 is necessarily positioned outside the vessel 60 when theposition sensor is outside the vessel 60.

As illustrated in FIG. 4D, a fluent closure composition precursor 70 isdelivered through the closure lumen 18 and out the precursor exit port22 after the precursor exit port 22 is determined to be outside thevessel 60. The fluent closure composition precursor 44 should havesufficiently low viscosity to allow the closure composition precursor toflow through the closure lumen 18. Once delivered, the closurecomposition precursor 44 accumulates adjacent the vessel 60. Thetransformation of the closure composition precursor to a non-fluentclosure composition serves to seal the vessel puncture 62. Energy canoptionally be delivered from the energy delivery device 28 to theclosure composition precursor as illustrated by arrows 72 in order tocause and/or accelerate transformation to the non-fluent closurecomposition. Alternatively or in addition, a catalyst can be added tocatalyze the conversion of the fluent precursor to a non-fluent closurecomposition.

FIG. 4E illustrates the withdrawal of the closure device 10.

In FIG. 4F the closure device 10 is completely withdrawn from the tissuesite 54 and pressure is being applied at the arrows 74 for a sufficientperiod of time after the closure composition precursor is delivered toallow the closure composition to transition to non-fluent closurecomposition.

The body 12 can optionally further include a locking mechanism 76 forcoupling the closure device 10 to the sheath 52. For example, asillustrated in FIGS. 5A and 5B, the locking mechanism 76 can be athreaded nut 78 complementary to threads 80 at the proximal end 14 ofthe sheath 52. When the closure device 10 is positioned within thesheath 52 the threaded nut 78 is turned to engage the threads 80 on thesheath 52 as illustrated in FIG. 5B. As a result, the sheath 52 andclosure device 10 move as a unitary body. Movement as a unitary body isdesirable to prevent the closure device 10 from moving relative to thesheath 52 when the closure device 10 is withdrawn from the tissue site54. Other mechanisms can be used to lock the closure device to a sheathincluding, for example, straps, snap-fit arrangements, bayonet locks,magnets, adhesives, and detents.

FIGS. 6A-6G illustrate a method of using the closure device 10illustrated in FIGS. 3A-3B which include a guidewire. As discussed withregard to the method illustrated by FIGS. 4A-4F, the method makes use ofa sheath 52 left in place after a surgical procedure. FIG. 6Aillustrates the sheath 52 in place in a tissue site 54 after thesurgical procedure.

As illustrated in FIG. 6B a guidewire 82 is inserted into the vessel 60through the sheath lumen 64.

Pressure is applied to the skin 56 upstream from the puncture 62 asshown by arrow 76 in FIG. 6C to prevent bloodflow through the vessel 60.The sheath 52 is then withdrawn from the tissue site 54 along theguidewire 82 as illustrated by arrow 84.

As illustrated in FIG. 6D, the guidewire 82 is then thread within theguidewire lumen 48 of the closure device 10 and the distal end 16 ispushed forward through the tissue site 54 until the position sensor 30indicates that the position sensor 30 is within the vessel 60. Thedistal end 16 of the closure device 10 preferably has the same or largerdiameter as the sheath used in the surgical procedure. Since thepuncture 62 has been dilated to the diameter of the sheath 52, thissizing reduces leakage of blood between the puncture 62 and the closuredevice 10.

As illustrated in FIG. 6E, the closure device 10 is slowly withdrawnfrom the vessel 60 until the position sensor 30 indicates that theposition sensor 30 is located outside the vessel 60. Since the precursorexit port 22 is positioned proximally relative to the position sensor30, withdrawal of the position sensor from the vessel 60 assures thatthe precursor exit port 22 has been withdrawn from the vessel 60.

As illustrated in FIG. 6F, once the precursor exit port 22 is determinedto be outside the vessel 60, a closure composition precursor 44 isdelivered through the closure lumen 18 and out the precursor exit port22 adjacent the vessel puncture 62.

FIG. 6G illustrates the complete withdrawal of the closure device 10from the tissue site 54. Pressure is applied at the arrows 86 untildesired transformation of the fluent closure composition precursor tothe non-fluent closure composition is substantially completed.

The energy delivery device 28 can be optionally used to deliver a formof energy which functions to accelerate the transformation of the fluentclosure composition precursor to non-fluent closure composition.Alternatively or in addition, a catalyst can be added to catalyze theconversion of the fluent precursor to a non-fluent closure composition.Most commonly, energy is used to increase the temperature of the closurecomposition precursor. In one embodiment, the energy delivery device 28is a microwave antenna positioned on or within the body 12. Theguidewire 82 can also include a microwave antenna. When microwave energyis employed, the closure composition precursor preferably includesmaterials capable of absorbing microwave energy. Examples of suchmaterials include, but are not limited to, hematite (a Fe2O3), maghemite(y-Fe2O3), magnetite (Fe3O4), geothite (□-FeOOH), lepidocrocite(y-FeOOH) ferrihydrite, feroxyhyte (δ-FeOOH), akageneite (β-FeOOH)graphite and amorphous carbon.

The energy delivery device 28 may also be a wave guide 88 for deliveryof UV, visible light or laser energy as illustrated in FIG. 7A. Theclosure device 10 includes a waveguide collar 90. FIG. 7B illustrates across section of the waveguide collar 90. A plurality of waveguides 88are arranged circumferentially around the collar. The light is providedto the waveguides 88 through a cable 92 coupled to a light source 94.

The energy delivery device 28 may also be an electrode for delivering RFenergy. The electrode can be a ring electrode encircling the body 12 asillustrated in FIG. 1A or a more localized electrode as illustrated inFIG. 2. The RF supply wires are run through the body 12 and coupled tothe energy source attachment port 30. Alternatively, RF energy may bedelivered to the closure composition precursor via the guidewire 82.Other types of energy 10 can also be used, including those that deliverultrasound, resistive heating, exothermic chemical heating, other formsof electromagnetic radiation, and frictional heating.

Referring again to FIG. 1A, one example of a position sensing mechanism34 is a pressure port coupled to the position monitor attachment port 38by a position lumen. The position monitor 40 is a pressure sensorcoupled to the position sensor attachment port by tubing. As a result,an open channel is created between the pressure port and the pressuresensor allowing the pressure sensor to detect the pressure at the port.The pressure within the vessel 60 is elevated compared with the pressurein the surrounding tissue. As a result, the signal from the pressuresensor indicates whether the position port is located within or outsidethe vessel 60.

The position sensing mechanism 34 can also be a contact switch 96 asillustrated in FIGS. 8A and 8B. The contact switch is coupled to theposition monitor attachment port 38 by wires run through the body (notshown). When the switch 96 is in contact with the vessel wall the switch96 closes and a circuit (not shown) is completed, however, when theswitch 96 is not in contact with the vessel wall, the switch 96 remainsopen and the circuit is not completed. The circuit is monitored todetermine the position of the closure device 10 relative to the vessel60. Alternatively, the circuit can be coupled to the energy deliverydevice 24 such that the energy cannot be delivered unless the circuit iscompleted. In one embodiment, the device includes a mechanism whichprevents the closure composition from being delivered if the positionsensor is sensed to be within the vessel. As a result, energy will notbe delivered unless the closure device 10 is properly positioned withinthe tissue site 54.

In a preferred embodiment, the closure device 10 includes two or moreposition sensors positioned around the closure device 10 where a readingthat the sensor is outside the vessel occurs when all of the sensors areoutside of the vessel. By having more than one position sensor aroundthe closure device 10, false readings from one of the position sensorsare reduced or avoided. For instance, if a single position sensingmechanism 34 is used, the sensing mechanism may become pressed againstthe vessel wall resulting in a pressure drop at the position sensingmechanism 34. The position monitor 40 would falsely provide a signalindicating that the position sensing mechanism 34 is outside the vessel60. When a second position sensing mechanism is included, the secondposition sensing mechanism would still be exposed to the pressure withinthe vessel 60. As a result, the position monitor 40 would not provide afalse signal. FIGS. 9A and 9B illustrate a closure device 10 with twoposition sensing mechanisms. In FIG. 9A, two pressure ports are coupledto a single position lumen. In FIG. 9B, each pressure port is coupled toa separate position lumen but both position lumens are coupled to thesame tubing before the tubing is coupled to the pressure sensor.

FIG. 9C illustrates another embodiment of the closure device 10according to the present invention. The closure device 10 includes aplurality of pressure ports 34 and a first closure composition port 20and a second precursor entrance port 46. An energy delivery port 30 iscoupled to a plurality of energy delivery devices 28. The closure device10 includes a guidewire lumen 48 for use with the method described inFIG. 6A-6G.

When the position sensing mechanism 34 is a contact switch or a pressureport, the position sensing mechanism 34 is preferably positioned atleast 25 mm from the distal end 16. This positioning assures that thedistal end 16 of the closure device 10 remains within the vessel 60 whenthe closure device is positioned to deliver the closure compositionprecursor. This feature reduces the risk of delivering the closurecomposition precursor to an improper location on the vessel or withinthe vessel.

FIGS. 10A and 10B illustrate another position sensing mechanism 34. Aballoon 98 is coupled to the distal end 16 of the closure device 10 by afirst and second retaining collar 99. The balloon is positioned over aninflation port 100. The balloon is coupled to an inflation bulb 102 byan inflation lumen 104 and an inflation tube 106. The balloon 98 isdeflated when the closure device 10 is positioned within the vessel 60.Once the balloon 98 enters the vessel 60, the balloon 98 is inflated toa diameter greater than the diameter of the sheath 52 and thus thepuncture 62. The closure device 10 is then withdrawn until theresistance of the balloon against the puncture 62 is felt as illustratedin FIG. 108. The resistance indicates that the precursor exit port 22 isoutside the vessel 60 and properly positioned for application of theclosure composition precursor.

FIG. 11 illustrates yet another embodiment of a position sensingmechanism 34. According to this embodiment, a curved wire 89 ispositioned within the vessel. As the vessel is withdrawn, resistance isfelt when the curved wire is pushed up against the interior of thevessel lumen. The closure precomposition ports are positioned such thatwhen the resistance is felt, the precomposition ports are known to bepositioned outside of the vessel.

Each position sensing mechanism 34 can be distally positioned 0.5-30 mmfrom the precursor exit port 22 and more preferably 3.0-9.0 mm from theprecursor exit port 22. These distances allow the closure compositionprecursor to be reliably delivered outside the vessel 60 once theclosure device 10 is positioned for delivery of the closure compositionprecursor.

A variety of additional sensors may be used in combination with thepresent invention. For example, temperature sensors may be positionedadjacent the distal end 16 of the closure device 10 for detecting thetemperature adjacent the distal end 16. The temperature sensors may be athermocouple positioned on the surface of the body 12 (not shown) andhardwired to electrical contacts within a sensor monitor attachment port(not shown). These sensors are useful for regulating the amount ofenergy being delivered to the vessel 60 and tissue adjacent the closuredevice 10 and for preventing tissue damage and ablation due to excessheat application.

Impedance sensors may also be employed when RF is used in order tomonitor the amount of energy being delivered to the tissue.

When the closure composition precursor is formed of two or morecomponents, the closure device 10 can optionally include a static mixer108 for mixing different closure composition precursor components beforethe closure composition precursors exit the precursor exit port or ports22. FIG. 12A illustrates a static mixer 108 incorporated into theclosure device 10. The first closure lumen 18 and the second closurelumen 42 intersect at least one time before terminating in at least oneprecursor exit port 22. The static mixer can also be a cartridge 110incorporated into the body 12 of the closure device 10 as illustrated inFIG. 12B. The intersection of the first and second lumens assures thatthe first and second closure composition precursors are mixed beforereaching the at least one precursor exit port 22.

The configuration of precursor exit ports can also serve to assureadequate mixing of the first and second closure composition precursors.As illustrated in FIG. 13, the precursor exit ports 22 corresponding tothe first closure composition alternate with the precursor exit portscorresponding with the second closure composition 112. As a result, thefirst and second closure composition precursors are mixed outside theclosure device 10.

A backflow valve 26 which is suitable for use in a closure lumen isillustrated in FIGS. 14A and 14B. The valve 26 has a compositionentrance 114 and a composition exit 116. FIG. 14A illustrates that whena fluid flows from the entrance 114 to the exit 116, a diaphragm 118slides forward to allow the closure composition precursor to flow freelythrough the valve 26. FIG. 14B illustrates that when a fluid flows fromthe exit 116 to the entrance 114, the fluid places pressure against thebackside of the diaphragm 118 causing the diaphragm 118 to slide againstthe entrance 114 sealing the entrance 114 and preventing a flow of fluidthrough the valve 26.

An example of a suitable backflow valve 50 for use in the central lumen48 adjacent the distal end of the device is a flapper valve 120 asillustrated in FIGS. 15A and 15B. Examples of backflow valves for thecentral lumen which may be positioned adjacent the proximal end of thedevice include, but are not limited to, duckbill valves, hemostasisvalves, and Tuhoy-Bourse valves. The flapper valve 120 is preferablyformed of an elastomeric material such as medical grade silicone rubber.The configuration, as illustrated by FIG. 15B, may be a cylindricalsection transitioning into a conical portion. The conical portion has aseries of slits 122 which allow various implements to pass through thevalve 50. The thickness of the flaps 124 and the flexibility of theelastomeric material will be balanced to provide memory sufficient toclose the puncture as the implements are withdrawn and provide a fluidseal. Blood pressure against the outer surface of the cone will causethe flapper valve 50 to close more tightly.

The body 12 is formed of any suitable, relatively flexible material.Suitable materials include, but are not limited to, polyethylene, PEBAXpolytetrafluroethylene (TEFLON) and polyurethane.

A variety of different closure composition precursors and non-fluentclosure compositions can be used in the present invention. The fluentclosure composition precursor and non-fluent closure composition shouldbe biocompatible and preferably bioresorbable. The closure compositionshould be also capable of forming a strong puncture seal and be able toseal larger sized vessel punctures, e.g., punctures formed by 8 frenchor larger needles. Examples of closure compositions that can be usedwith the device and method of the present include, but are not limitedto sealants and adhesives produced by Protein Polymer Technology(Ethicon); FOCALSEAL produced by Focal; BERIPLAST produced by Centeon(JV Behringwerke & Armour); VIVOSTAT produced by ConvaTec(Bristol-Meyers-Squibb); SEALAGEN produced by Baxter; FIBRX produced byCyoLife; TISSEEL AND TISSUCOL produced by immuno AG; QUIXIL produced byOmrix Biopharm; a PEGcollagen conjugate produced by Cohesion (Collagen);HYSTOACRYL BLUE produced by Davis & Geck; NEXACRY, NEXABOND, NEXABONDS/C, and TRAUMASEAL produced by Closure Medical (TriPoint Medical);OCTYL CNA produced by Dermabond (Ethicon); TISSUEGLU produced byMedi-West Pharma; and VETBOND produced by 3M. Examples of two partclosure compositions which may be used are listed in Table 1. CLASS OFADHESIVE PART A PART B (Meth) Acrylic (Meth)acrylic functional(Meth)acrylic (redox initiated) monomers and oligomers functionalmonomers with oxidant initator and oligomers with reductant initatorPolyurethane Poly isocyanate Hydrocarbon polyol, polyether polyol,polyester polyol Polyurea Poly isocyanate Hydrocarbon polyamine,polyether polyamine Ionomer Polyvalent metal cation Acrylic acid(co)polymer, alginate Epoxy Epoxy resin Aliphatic polyamine, catalyst

While the present invention is disclosed by reference to the preferredembodiments and examples detailed above, it is to be understood thatthese examples are intended in an illustrative rather than limitingsense, as it is contemplated that modifications will readily occur tothose skilled in the art, which modifications will be within the spiritof the invention and the scope of the appended claims.

1. An assembly for introducing a closure material to seal a vesselpuncture site, the closure material comprising a mixture of a first andsecond fluid composition which, upon mixing, react to form a nonfluentclosure composition, the assembly comprising a catheter for passagethrough a tissue puncture and having a distal end, at least one fluiddelivery port adjacent the catheter distal end to occupy a positionadjacent the vessel puncture site, and a lumen in the catheter in fluidcommunication with the fluid delivery port, one or more dispensers influid communication with the catheter lumen for dispensing the first andsecond fluid compositions in the catheter lumen, and an actuator forcausing the first and second fluid compositions to be dispensed from theone or more dispensers mixed by flowing the first and second fluidcompositions through a static mixer incorporated in the catheter anddispensed from the fluid delivery port as a fluid mixture that reacts insitu to form the nonfluent closure composition adjacent the vesselpuncture site, wherein the catheter is sized to block flow of the fluidmixture from the fluid delivery port into a substantial part of thetissue puncture, whereby a localized in situ closure forms adjacent thevessel puncture site to seal the vessel puncture site.